Methods for making a connection and connector assemblies

ABSTRACT

A method of making a sterile connection comprises mating a first fitting having an aperture and a second fitting having an aperture, removing first and second strip out layers from between the end surfaces of sealed first and second resilient sealing members, and contacting the end surfaces of the resilient sealing members to provide fluid communication between the aperture of the first fitting and the aperture of the second fitting. A connector assembly comprises first and second fittings, a stem mounted for axial movement through the first fitting into the second fitting, and a deformable locking device which selectively prevents axial movement of the stem in the first fitting.

This application is a continuation of U.S. application Ser. No.11/412,981, filed on April 28, 2006, which is a continuation of U.S.application Ser. No. 10/929,769, filed on Aug. 31, 2004, and issued asU.S. Pat. No. 7,090,191, which is a continuation of U.S. applicationSer. No. 10/685,431, filed on Oct. 16, 2003, and issued as U.S. Pat. No.6,880,801, which is a continuation of U.S. application Ser. No.09/423,374, filed on Jun. 26, 2000, and issued as U.S. Pat. No.6,655,655, which is a United States national phase application ofPCT/US98/09653, filed on May 8, 1998, which claims priority to U.S.application Ser. No. 60/046,051, filed on May 9, 1997, all of which areincorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to methods for making a connection andconnector assemblies. More particularly, the invention relates tomethods for making a connection and connector assemblies which maintainthe sterility of a fluid which passes through them.

BACKGROUND OF THE INVENTION

Connector assemblies have been developed to handle fluids, e.g.,biological fluids, while preserving their condition. More particularly,connectors have been developed to preserve the condition of a fluid, ormaintain a fluid free of contaminants. Freedom from contaminants refersto a relative amount of contaminants and is variously defined accordingto a specific industry, fluid and/or intended use. For example, abiological fluid is considered free of contaminants if it issubstantially free of viable microorganisms and is typically referred toas “sterile”. Connector assemblies for use with biological fluids, forexample, have been fashioned to preserve sterility of the fluid.

Attempts have been made to develop connector assemblies which isolate afluid from the ambient environment of the connector, and fromcontaminants entrained in the ambient environment. Such connectorstypically define a fluid conduit, the interior of which is isolated fromthe ambient environment. Some conventional connector assemblies includemating male and female connectors having opposing surfaces and aremovable protective cover on each opposing surface to be contacted.These covers must be removed prior to actually coupling the connectors.

A problem associated with these conventional connector assemblies inwhich protective covers must be removed prior to coupling is thatremoving the covers may not sufficiently protect the fluid flowingthrough these assemblies. To unfasten and remove a cover, a technicianmust manually manipulate the removable cover in intimate proximity tothe protected region under the cover, risking incidental contact and thetransmission of contaminants to the protected region.

In addition, once the protective covers are removed from the protectedsurfaces, the protected regions are exposed to the contaminant-ladenambient environment. For example, as the connectors are broughttogether, dust, micro-organisms, and other airborne contaminants maycontact the protected regions, even if the connectors are quickly mated.Thus, while these conventional connector assemblies have been developedto form a sterile connection, none adequately protect the fluid flowingthrough the connector assembly.

Another type of conventional connector assembly comprises mating maleand female fittings, each fitting having a protective cover attached toa connecting end of the fitting, and a piercing member inside the malefitting to pierce the protective covers and join the interiors of themating fittings. One problem with these fittings is that the piercingmember may prematurely pierce the cover before the fittings are coupledtogether. As a result, contaminants may enter the connector and it musteither be resterilized or discarded.

Another problem which may occur with conventional connector assembliesincluding piercing members is that the piercing member may sever aportion of one or both of the covers between the connecting ends of themale and female fittings when the fittings are coupled together. Thesevered portion of the membrane may enter a fluid flow path defined bythe interior region of the fittings and contaminate the system orinterfere with the flow of fluid through the connector.

Another problem that exists with conventional connector assemblies isobtaining a good seal between the male and female fittings. When theprotective covers covering the connecting ends are removed and theconnecting ends of male and female fittings are joined, there may begaps between the joined connecting ends due to unmatched surfaces. Thegaps may allow contaminants to enter and compromise the sterility of theinner region of the fittings. Thus, there exists a need for a sterileconnector assembly which provides a good seal between opposingconnecting ends of the male and female fittings.

Another problem associated with conventional connectors havingprotective covers is that, prior to assembly of the connectors, theprotective covers are exposed. Consequently, when the connectors arehandled, the protective covers may be easily damaged or punctured, oraccidentally or inadvertently removed. As a result, the contaminants mayenter the connectors, and the connectors must be discarded. In somecases, the damages to the protective covers may not be easilydiscovered, and contaminated connectors may be unknowingly used and thefluid flowing through the connector assembly may be contaminated.

SUMMARY OF THE INVENTION

Various aspects of the present invention overcome many of the problemsassociated with the conventional connector assemblies, including many ofthe problems previously outlined.

In accordance with one aspect of the invention, methods of making asterile connection may comprise mating a first fitting having anaperture and a second fitting having an aperture. Mating the fittingsmay include positioning an end surface of a first hollow resilientsealing member opposite an end surface of a second hollow resilientsealing member and positioning first and second strip out layers betweenthe end surfaces of the first and second resilient sealing members.Mating the fittings may also include mechanically interlocking theproximal ends of the fittings with the first strip out layer sealing thefirst resilient sealing member of the first fitting and the second stripout layer sealing the second resilient sealing member of the secondfitting. The methods of making a sterile connection may further compriseremoving the first and second strip out layers from between the endsurfaces of the sealed first and second resilient sealing members andcontacting the end surface of the first resilient sealing member and theend surface of the second resilient sealing member to provide fluidcommunication between the aperture of the first fitting and the apertureof the second fitting.

In accordance with another aspect of the invention, connector assembliesmay comprise a first fitting, a second fitting, a stem, and a deformablelocking device. The first fitting may have an aperture. The secondfitting also may have an aperture and may be coupleable to the firstfitting. The stem may be disposed in the aperture of the first fitting.The stem may include a head and may be axially movable through theaperture of the first fitting into the aperture of the second fitting.The deformable locking device may include an axially extending memberarranged between the first fitting and the stem to selectively preventthe head from moving through the aperture in the first fitting.

The novel features and characteristics of this invention are set forthwith particularity in the appended claims. However, the invention maybest be understood with reference to the drawings, described below, andthe accompanying detailed description of preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a connector assembly according to an embodimentof the present invention.

FIG. 2 is a side view in partial section of the connector assembly ofFIG. 1.

FIG. 3 is a side view in partial section of the connector assembly withthe stripout layers removed and the stem inserted into the femalefitting.

FIG. 4 is an end view of a male connector in an unconnected state.

FIG. 5 is an end view of a female connector in an unconnected state.

FIG. 6 is a sectional view of a male sealing member.

FIG. 7 is a sectional view of a female sealing member.

FIG. 8 a is a side view in partial section of the male connector cap.

FIG. 8 b is a side view in partial section of the female connector cap.

FIG. 8 c is a top view of the male or female connector cap.

FIG. 9 is a side view in partial section of a connector assemblyaccording to another embodiment of the present invention.

FIG. 10 is a bottom view in partial section of the male connector ofFIG. 9.

FIG. 11 is an elevation view, in partial section, of disassembledcomponents of a fluid system according to another embodiment of thepresent invention.

FIG. 12 is an elevation view, in partial section, of disassembledcomponents of a fluid system according to another embodiment of thepresent invention.

FIG. 13 is an elevation view of a fluid system according to anotherembodiment of the present invention.

FIG. 14 is an elevation view, in partial section, of disassembledcomponents of the fluid system of FIG. 11.

FIG. 15 is a diagram of the connector assembly of FIG. 1, which is usedto make a dry connection.

DETAILED DESCRIPTION OF THE INVENTION

A connector assembly according to an embodiment of the present inventionincludes mating connectors which can be coupled to connect differentfluid conduit sections defining a fluid flow path, e.g., a liquid flowpath. The connector assembly isolates the fluid flow path from theambient environment and from contaminants present in the ambientenvironment and is preferably sterile. Consequently, a connectorassembly according to the present invention is suitable for use in anopen system, a closed system, or a closed sterile system.

In an embodiment illustrated in FIGS. 1-7, the connector assemblycomprises two connectors, preferably a female connector 100 and a maleconnector 200. Each connector may be attached to or formed as part ofany suitable fluid container or conduit, for example, a section oftubing, an inlet or outlet of a housing, such as a filter housing ordrip chamber housing, or a flexible bag such as a blood bag. Eachconnector may comprise any structure suitable for fluid communication,preferably liquid communication, e.g. a housing of any form capable ofcontaining fluid. The exemplary female connector 100 generally comprisesa fitting 120, preferably of unitary construction. An exemplary maleconnector 200 generally comprises a stem 210 and a fitting 220. Thefittings 120,220 of the female and male connectors 100,200 arepreferably formed from a polymeric material. For example, the fittings120,220 may be molded from a polymeric material such as polycarbonate orpolypropylene.

For directional orientation in the following discussion, each connectorhas a proximal end, nearest the opposing connector, and a distal endfurthest from the opposing connector. Also, since the exemplaryconnectors 100, 200 in FIG. 1 comprise generally elongated bodies, theterm axial denotes disposition along their axes.

The female and male connectors 100, 200 may also comprise aninterlocking mechanism adapted to interlock the female connector 100 inpredetermined relation with the male connector 200. The interlockingmechanism may have any suitable configuration, such as interlockingsleeves or threaded connections. In a preferred embodiment, the portionof the interlocking mechanism on the female fitting 120 may include abracket 140. The bracket 140 may be variously configured. The bracket140 may comprise a socket 145 or cup having any suitable plan form, e.g.rectangular or circular. In the illustrated embodiment, the bracket 140comprises a generally C-shaped member. The representative bracket 140may include a flange 142 and a generally cylindrical sidewall 144defining a socket 145. The flange 142 may assume a radially extendingannular plan form, for example, as best seen in FIG. 5. In theembodiment of FIG. 3, the sidewall 144 extends from and is concentricwith the flange 142 and includes an annular proximal end surface 143facing the male connector 200.

One or more forks 146 may extend from the flange 142. The forks 146 maybe formed integrally with the flange 142. When the female connector 100is coupled to the male connector 200, the forks 146 preferably registerin slots 240 formed in an upper flange 242 of the male connector 200.While in the illustrated embodiment, the forks 146 extend from thefemale connector 100 and the slots 240 are in the male connector 200,the forks and slots may instead be associated with the male and femaleconnectors, respectively. The forks 146 are best illustrated in FIG. 5.The slots 240 are best illustrated in FIG. 4. Each fork 146 preferablycomprises first and second prongs 147 which are preferably flexible toallow the prongs 147 to enter and lock in the slots 240. Catches 148 canbe formed on the prongs 147 of the forks 146 which pass through theslots 240 and abut a distal surface of the upper flange 242. In thismanner, the forks 146 extend through the slots 240 and engage the upperflange 242 of the male connector 200 to interlock the connectors 100,200.

The female connector 100 is preferably adapted to contain fluid andconduct fluid communication and preferably defines an isolated portionof the fluid flow path, e.g., containing or conducting isolated fluidcommunication. The female fitting 120 may define an internal chamber oraperture 132 which may have any suitable configuration and preferablyhas an open proximal end. The distal end 126 of the female fitting 120may be connected to any suitable fluid container or conduit as bestshown on FIGS. 11-14. For example, the distal end 126 of the femalefitting 120 may be bonded to a section of tubing 10 or to the top, thebottom or the wall of a container using any suitable bonding technique.Alternatively, the female fitting 120 may be molded integrally with thetubing 10 or the container. The fluid conduit or container may beconnected in fluid communication with the internal chamber 132 of thefemale fitting 120. The internal chamber 132 may comprise a bore 134relieved at its proximal end into a counterbore 136 having a largerinner diameter than the bore 134. The cylindrical sidewall 144 surroundsthe proximal end of the chamber 132 and defines the counterbore 136.

The female connector 100 preferably further comprises a sealing layersealing the open proximal end of the aperture 132 in the female fitting120. For example, the sealing layer preferably comprises a removablesealing layer, such as a female stripout layer 300 removably attached tothe proximal end of the female fitting 120. In the illustratedembodiment, the female stripout layer 300 is attached to the openproximal end of the sidewall 144. For example, the female stripout layer300 may be bonded to the proximal end surface 143 of the female fitting120 through any suitable technique, for example, ultrasonic welding. Thestripout sealing layer 300 preferably seals the chamber 132 of thefemale connector 100 from the ambient atmosphere. The female stripoutsealing layer 300 preferably includes a pull tab that extends beyond theperiphery of the connectors 100, 200 to allow removal when theconnectors 100, 200 are joined.

The male connector 100 also preferably comprises a sealing layer whichseals the open proximal end of an aperture 232 in the male fitting 220.For example, the sealing layer preferably comprises a removable sealinglayer such as a male stripout layer 310 removably attached to theproximal end of the male fitting 220. In the illustrated embodiment, themale stripout layer 310 is attached to the proximal end surface 243 atthe open end of a generally cylindrical sidewall 244 at the proximal endof the male fitting 220. The inner and outer diameters of the malesidewall 244 may be approximately equal to those of the female sidewall144. The male stripout sealing layer 310 may be bonded to the proximalend surface 243 of the male connector through any suitable technique,for example, ultrasonic welding. The male stripout sealing layer 310preferably seals the interior of the male connector 200 from the ambientenvironment. The male stripout sealing layer 310 preferably includes apull tab that extends beyond the periphery of the connectors 100, 200 toallow removal when the connectors 100, 200 are joined.

When the female and male connectors 100, 200 are initially connected,the female and male stripout sealing layers 300, 310 preferably abut oneanother in face-to-face contact. For example, the diameters andlocations of the female and male sidewalls 144, 244 and the lengths ofthe forks 146 and the sidewalls 144, 244 may be arranged to provideface-to-face contact of the stripout layers 300, 310 between the endsurfaces 143, 243 of the sidewalls 144, 244 when the connectors 100, 200are coupled. The dimensions may be arranged to provide not only contactbut also a slight compression of the stripout layers 300, 310 betweenthe end surfaces 143, 243. However, the compression is preferably not solarge as to interfere with the removal of the stripout layers 300, 310from between the sidewalls 144, 244. Of course, if the female and maleconnectors 100, 200 include non-removable sealing layers, rather thanthe stripout sealing layers 300, 310, then the compression may besomewhat larger. Alternatively, the dimensions and locations of theforks 146 and the sidewalls 144, 244 may be arranged to provide a slightspace between the female and male stripout layers 300, 310. For example,the combined length of the sidewalls 144, 244 may be less than thedistance between the flanges 142, 242. Preferably the space issufficiently small to prevent significant axial movement of theconnectors 100, 200 when they are connected to one another.

The stripout layers 300, 310 may comprise impermeable materials, such asglassine paper, metal foils, or impermeable polymeric films, orpermeable materials, including papers such as Tyvek™ paper or porouspolymeric films, which preclude the passage of bacterial contaminants. Apreferred impermeable material is an aluminum foil which is removablysealed to the fitting 120,220. Permeable or porous materials offer theadvantage, if desired, of allowing sterilizing gases, including ethyleneoxide gas, to penetrate therethrough and spread to the interior of thefemale and male connectors 100, 200, thereby sterilizing them withouthaving to remove the stripout layers 300, 310. Either permeable orimpermeable materials may be suitable for gamma or heat sterilization.Additionally, a bacteriostatic or bacteriocidal compound or layer (notillustrated) may be disposed on either or both stripout layers 300, 310.The female stripout layer 300 may be the same as or different from themale stripout layer 310.

Although the illustrated embodiment depicts female and male connectors100, 200 both with connecting ends sealed by removable sealing layers300, 310, one or both of the connectors 100, 200 may additionallyinclude a separate sealing layer, such as a pierceable membrane layer,which is not removable and is sealed to the connector under the stripoutlayer to provide an added level of sterility assurance. In otheralternatives, the connectors 100, 200 may both include proximal endssealed by sealing layers which are not removable, and the stripoutlayers may be omitted; or one connector may include only a stripoutsealing layer while the other connector includes only a non-removablesealing layer.

One, preferably both, of the connectors 100, 200 may also include adevice which protects the proximal end of the connector 100, 200 andprevents the stripout layer 300, 310 from being inadvertently puncturedor removed prior to assembly of the connectors 100, 200. Preferably thedevice is operatively associated with the proximal end of the connector100, 200 and can be easily removed prior to the assembly of theconnectors 100, 200. As shown in FIGS. 8 a, 8 b and 8 c, an exemplaryembodiment of the device may be a cap 183, 283 which may include a cover189, 289, a tab 186, 286 attached to the cover, a cylindrical sleeve184, 284, and a plurality of ribs 185, 285. Preferably the cover 189,289 has a dome-shaped configuration, although the cover 189, 289 mayhave any other suitable configuration such as a cylindricalconfiguration. One of the ends of the sleeve 184, 284 is attached to theinner surface of the cover 189, 289. When the cap 183, 283 is mounted tothe proximal end of the connector 100, 200, the other end of the sleeve184, 284 bears against the end 143, 243 of the sidewall 144, 244, andthe ribs 185, 285 engage the flange 142, 242 of the connector 100, 200.Thus, the sleeve 184, 284 and the ribs 185, 285 allow the cap 183, 283to be securely mounted to the proximal end of the connector 100, 200.Further, the sleeve 184, 284 presses the stripout layer 300, 310 againstthe end 143, 243 of the sidewall 144, 244, holding the stripout layer300, 310 in place and preventing it from being torn off. Preferably theheight of the cover 189, 289 and the length of the sleeve 184, 284 arechosen such that the parts of the connector 100, 200 at the proximal endof the connector 100, 200, such as the stripout layers 300, 310 and theforks 146, can be contained in and protected by the cap 183, 283.Further, the tab 186, 286, which may be attached to the outer peripheryof the cover 189, 289, preferably is sufficiently long such that thepulling tab 300, 310 are contained in and protected by the tab 186, 286.To make the cap 183, 283 easily removable, the cap 183, 283 may includea strip 187, 287 defined by perforations 188, 288 and connected to thetab 186, 286. Therefore, the cap 183, 283 can be easily removed from theconnector 100, 200 by pulling the tab 186, 286 and tearing the strip187, 287 along the perforations 188, 288. Once the strip 187, 287 istorn but may still be attached to the cap 183, 283, the cap 183, 283 canbe easily removed from the connector 100, 200.

The cap 183, 283 may be formed from any suitable material which providesthe cap 183, 283 with sufficient structural integrity and issufficiently pliable such that the strip 187, 287 can be easily tornalong the perforations 188, 288. Preferably the cap 183, 283 is formedfrom a plastic material or a metallic material, such as aluminum oraluminum alloy. More preferably the cap 183, 283 is formed from apolymeric material such as polycarbonate or polypropylene.

In accordance with one aspect of the present invention, the connectorassembly includes at least one resilient sealing member, such as a malesealing member 270 disposed at the proximal end of male connector 200.For example, the male sealing member may be enclosed in a socket 245formed on the proximal end of the male connector 200 and having an openend. In the illustrated embodiment, for example, in FIG. 2 and FIG. 3,the socket 245 is defined by the annular sidewall 244 at the connectingend of the male connector 200, and the open end comprises the proximalend surface 243 of the side wall 244. The socket 245 preferablycompletely surrounds the male sealing member 270; e.g., the side wall244 preferably comprises a continuous, unbroken cylindrical wall whichcompletely surrounds the male sealing member 270. The socket 245 and themale sealing layer 310 preferably sealingly contain the resilientsealing member.

The male sealing member 270 can be variously configured. For example,the male sealing member 270 may comprise a resiliently compressible andexpandable member including a hollow body having opposite open ends andan interior passage extending between the open ends, as illustrated inFIGS. 2, 3, and 6. The male sealing member 270 preferably comprises anannular base portion 271, neck portion 272, and head portion 273. Thebase portion 271 preferably comprises an annular rim having a slightlylarger outer diameter than the inner diameter of the sidewall 244 andbeing adapted to form a tight frictional fit with the sidewall 244 whenit is inserted in the socket 245 of the male connector 200. The baseportion 271 may include a beveled surface 275 along its outer diameterto allow the base portion 271 to be inserted in and slide to the bottomof the socket 245.

The neck portion 272 of the male sealing member 270 preferably forms anannular wall joining the base portion 271 and the head portion 273. Thewall of the neck portion 272, which is preferably thinner than the wallof the base portion 271 and thinner than the wall of the head portion273, is preferably resiliently compressible to allow the male sealingmember 270 to be compressed within the socket 245 of the male connector200 by the male stripout layer 310. In the illustrated embodiment, thelength of the male sealing member 270 is greater than the length of themale sidewall 244 and the thin wall neck portion 272 has an innerdiameter equal to, and an outer diameter less than, those of the baseportion 271 and the head portion 273. The neck portion 272 resilientlycollapses, e.g., bends radially outwardly, to allow the sealing member270 to be compressed within the socket 245 of the male connector 200.Alternative structures for the neck portion 272 are within the scope ofthe present invention. For example, the neck portion 272 may have alarger inner diameter than those of the base portion 271 and headportion 273 and may bend radially inward, or the neck portion 272 maycomprise a bellows-like member having multiple bends when the malesealing member 270 is compressed.

The head portion 273 preferably comprises a beveled inner surface 277and an annular rim which is formed on an end of the male sealing member270 opposing the base member 271. Further, the head portion 273, as wellas the neck portion 272, preferably has an outer diameter which issmaller than the outer diameter of the base portion 271 and is smallerthan the inner diameter of the side wall 244 forming the socket 245.Because the outer diameters of the head portion 273 and the neck portion272 are smaller than the inner diameter of the socket 245 and are spacedfrom the side wall 244 of the socket 245, they easily expand axiallywithin the socket 245 without seizing or catching against the side wall244. Thus, the head portion 273 and the neck portion 272 may resilientlyexpand from within the socket 245 to form a tight seal with the femaleconnector 100 when the stripout layers 300, 310 are removed.

There are many alternative ways by which the male sealing member may beconfigured. Shown in FIG. 9, for example, is an alternativeconfiguration. The male sealing member 470 shown in FIG. 9 is similar tothe male sealing member 270 shown in FIG. 6 but has a head portion 473and a base portion 471, which have substantially the same outerdiameter. The socket 445, on the other hand, has a continuouscylindrical wall including an interior step in which the inner diameterof the distal portion of the socket wall 444 is smaller than that of theproximal portion of the socket wall 444. Preferably the inner diameterof the distal portion of the socket wall is slightly less than the outerdiameter of the base portion 471 and is adapted to form a tightfrictional fit with the base portion 471 when the male sealing member470 is inserted in the socket 445. The inner diameter of the proximalportion of the socket wall 444 preferably is larger than the outerdiameters of the head portion 471 and the neck portion 472 such that thehead and the neck portions 471, 472 can easily expand axially within thesocket 445 without seizing or catching against the proximal portion ofthe socket wall 444.

Although the illustrated embodiments depict the male sealing member 270,470 as having a constant inner diameter and a varying outer diameter, amale sealing member with a constant outer diameter and variable innerdiameter is within the scope of the invention. As long as the malesealing member is resiliently compressible and expandable, the malesealing member may have a varying inner diameter rather than a varyingouter diameter. Alternatively, the male sealing member may have avarying inner diameter and a varying outer diameter or a constant innerdiameter and a constant outer diameter.

A second sealing member, for example, a female sealing member 170, maybe disposed in the socket 145 of the female connector 100. The socket145, which also has an open end, includes the sidewall 144, which ispreferably continuous and completely surrounds the female sealing member170, and the proximal end surface 143 of the female fitting 120. Thefemale sealing member is preferably sealingly contained within thesocket 145 and the female stripout layer 300.

The female sealing member 170 may be variously configured. For example,the female sealing member 170 may also comprise a resilientlycompressible and expandable member including a hollow body havingopposite open ends and an interior passage extending between the openends, as shown in FIGS. 2, 3, and 7. The female sealing member 170preferably comprises a base portion 171 and a head portion 173. The baseportion 171 preferably comprises an annular rim having an outer diameterlarger than the inner diameter of the sidewall 144 and being adapted toform a tight frictional fit with the socket 145 of the female connector100. The base portion 171 preferably also includes a beveled outersurface 175 to facilitate insertion of the female sealing member 170into the bottom of the socket 145.

The head portion 173, as well as the base portion 171, preferablycomprises a resiliently compressible material to allow the femalesealing member 170 to be compressed within the socket 145 of the femaleconnector 100. The head portion 173 preferably has an outer diameterwhich is smaller than the outer diameter of the base portion 171 and issmaller than the inner diameter of the side wall 144 forming the socket145. Because the outer diameter of the head portion 173 is smaller thanthe inner diameter of the socket 145 and is spaced from the side wall144 of the socket 145, the head portion 173 easily moves axially withinthe socket 145 without seizing or catching against the side wall 144.Thus, the head portion 173 may resiliently expand within the socket 145to form a tight seal with the male connector 200 when the stripoutlayers 300, 310 are removed. The head portion 173 preferably comprisesan inner diameter and a beveled inner surface 177 which mirror the innerdiameter and the beveled inner surface 277 of the male sealing member270 to form an annular indention 163 in an inner surface of the joinedsealing members 170, 270 when the stripout layers are removed. Further,the head portion 173 may have a thinner wall than that of the baseportion 171.

There are also many alternative ways by which the female sealing membermay be configured. Shown in FIG. 9, for example, is an alternativeconfiguration. The female sealing member 370 shown in FIG. 9 is similarto the female sealing member 170 shown in FIG. 7 but has a uniform outerdiameter. The socket 345, on the other hand, has a continuouscylindrical wall including an interior step in which the inner diameterof the distal portion of the socket wall 344 is smaller than that of theproximal portion of the socket wall 344. Preferably the inner diameterof the distal portion of the socket wall 344 is slightly less than theouter diameter of the female sealing member 370 and is adapted to form atight frictional fit with the female sealing member 370 when the femalesealing member 370 is inserted in the socket 345. The inner diameter ofthe proximal portion of the socket wall 344 preferably is larger thanthe outer diameter of the female sealing member 370 such that the femalesealing member 370 can easily expand axially within the socket 345without seizing or catching against the proximal portion of the socketwall 344.

The sealing member or members provide several advantages. For example,each sealing member 170, 270 may be formed from a different materialthan the material forming the fittings 120, 220. In particular, eachsealing member may be formed from a material which is more resilient,e.g., more resiliently compressible and expandable, than the more rigidmaterial forming the fittings 120, 220. Exemplary materials for thesealing members include resiliently compressible and expandablepolymeric materials or elastomeric materials. A preferred material is aTPE (thermoplastic elastomer), such as a Santoprene TPE. The enhancedresiliency of the sealing member(s) provides a greatly improved seal.

Another advantage of the sealing member or members is that the endsurface of the head portion 173, 273 may be formed very evenly,providing an excellent seal. In preferred embodiments, the end surfacesof the head portions 173, 273 of the contained sealing members 170, 270abut but are not joined to the stripout layers 300, 310, i.e., thestripout layers are joined only to the end surfaces 143, 243 of thecylindrical walls 144, 244. This allows the end surfaces of the headportions 173, 273 to remain even and clean and, thereby, form a tightseal free of any leachants. Of course, in less demanding applications,the stripout layers may be joined to both the sidewalls and the sealingmembers or only to the sealing members.

Although the illustrated embodiment depicts the female sealing member170 being sealed in the socket 145 of the female connector 100 by thefemale stripout layer 300, and the male sealing member being compressedand sealed within the socket 245 of the male connector 200 by the malestripout layer 310, alternative arrangements are within the scope of thepresent invention. For example, the male sealing member 270 may bedisposed in the socket 145 of the female connector 100, and the femalesealing member 170 may be disposed in the socket 245 of the maleconnector 200. Alternatively, the female sealing member 170 may beomitted. In an embodiment in which the female sealing member 170 isomitted, the male sealing member 270 may be disposed within the socketof either connector by a stripout layer or a non-removable sealinglayer.

In an embodiment which includes a single sealing member, when thestripout layer is removed, the sealing member may abut a surface on theconnecting end of the opposing connector to seal the connector assembly.For example, if the male sealing member 270 is disposed in the socket245 of the male connector 200, the head portion 273 of the connector maycontact a surface 135 in the counterbore 136 of the female connector100. Alternatively, the sidewall 144 of the female connector may bethickened in a radially inward direction to extend inwardly beyond thesidewall 244 of the male connector and provide a contact surface for themale sealing member 270. The male connector 200 preferably includes astem 210 telescopically housed in a generally cylindrical body 221defining the aperture 232 in the male fitting 220. The male connector200 is also preferably adapted to contain and conduct fluidcommunication and preferably defines an isolated portion of the fluidflow path, e.g., containing or conducting isolated fluid communication.Accordingly, the stem 210 is preferably sealed within the aperture 232defined by the fitting 220. In the illustrated embodiment, the stem 210includes a seal 252 coupled between a distal end 226 of the stem 210 andthe body 221 of the male connector 200. The seal 252 may comprise ano-ring disposed around the stem 210. In an alternative embodiment, theseal 252 may be disposed in a groove in the interior wall of the body ofthe male connector 200. The seal 252 preferably sealingly and slidablyengages an interior wall to seal the aperture 232 from the ambientenvironment and allow the stem 210 to move axially.

While the stem 210 may be arranged to move axially only with respect tothe female connector 100 and to be stationary with respect to the malefitting 220, the stem 210 is preferably arranged to move axially bothwith respect to the female connector 100 and the male fitting 220. Forexample, the stem 210 preferably moves axially through the male fitting220; e.g., through the aperture 232 and the open proximal end of theaperture 232, through the socket 245 and the open end of the socket 245,through the male sealing member 270 including the open ends and theinterior passage, and/or through any non-removable sealing layer.Further, the stem 210 preferably moves axially into the female connector100; e.g., through any non-removable sealing layer, through the femalesealing member 170 including the open ends and the interior passage,through the open end of the socket 145 and the socket 145, through theopen end of the aperture 132, and/or into the aperture 132. Because thestem 210 moves through the female and/or male sealing members, thelargest outer diameter of the stem 210 is preferably smaller than thesmallest inner diameter of the interior passages of the sealing members170, 270. Further, the proximal portion of the stem 210 preferably istapered and has a bullet-shaped configuration, as shown in FIG. 9. Thisfacilitates axial movement of the stem 210 without disturbing the sealformed by the sealing members 170, 270. Alternatively, the diameters maybe approximately equal to create a seal between the stem 210 and thesealing member or members 170,270.

The stem 210 is preferably hollow, defining a lumen (not shown) therein.The proximal end of the stem 210 may have a head 250 formed thereon. Thehead 250 may have an aperture providing fluid access between the lumenand the exterior of the stem 210. The head 250 may comprise a bluntmember or a piercing member, depending on whether or not the sealinglayers include non-removable layers. For example, if the sealing layersinclude non-removable layers in addition to stripout layers, the head250 preferably comprises a piercing member to pierce the non-removablelayers and provide fluid communication between the interior regions ofthe male and female connectors 200, 100. If separate non-removablelayers are not included, the head 250 may comprise a blunt member. Thehead 250 may be blunt because once the stripout members are removed,there are no obstructions which require piercing between the male andfemale connectors 200, 100.

The stem 210 may also be connected to a fluid container or conduit 20 asbest shown on FIGS. 11, 12, and 14. For example, a conduit 20, such as asection of tubing, may be connected to the distal end 226 of the stem210 in any suitable manner, e.g., by using solvents, bonding agents,hose clamps, ultrasonic welding, threaded connectors, or frictionfitting. Alternatively, the tubing 20 or container may be moldedintegrally with the stem 210.

According to another aspect of the present invention, the stem 210 mayinclude a locking device. The locking device 260 may be of anyconfiguration that restricts the accidental or inadvertent axialadvancement of the stem 210. In the embodiment illustrated in FIG. 1,the locking device comprises two locking tabs 260 rigidly extendingaxially from a lower flange 224 of the body 221 to a flange 228 on thestem 210. The number of locking tabs 260 is not critical to theinvention. For example, a single locking tab 260 may be included, ormore than two locking tabs 260 may be included. If multiple locking tabs260 are included, they are preferably located at equally spacedcircumferential locations about the stem 210 to uniformly distributeforce applied to the stem 210.

In the embodiment shown in FIG. 1, the locking tabs 260 compriseradially projecting fins which extend axially between the flanges 224,228. The locking tabs 260 may be deformable, e.g., may be arranged tobend out of the way or to break away from one or both of the flanges224, 228. For example, the locking tabs 260 may be attached at bendableor frangible joints 262 to the flange 228 and/or the barrel of the stem210. The locking tabs 260 are preferably not attached to the distalflange 224 of the male fitting 220. Thus, each locking tab 260 may beeasily grasped and bent in a direction perpendicular to the plane of thetab 260, breaking the frangible joint and freeing the stem 210 to moveaxially. In an alternative embodiment, the locking device may comprise apermanently attached, non-breakable arrangement, such as a radiallyextending key on the stem 210 and a keyway on the body 221 which allowsthe axial movement of the key, and stem 210 after the key is alignedwith the keyway. Alternatively, the stem 210 may include one or morekeyways and the body 221 may include one or more keys.

Shown in FIGS. 9 and 10 is a preferred embodiment of the locking device460. The locking device 460 may comprise one or more wings 461 extendingradially from the surface of the stem 210, although the locking device460 shown in FIGS. 9 and 10 comprises two wings 461. The wings 461extend radially beyond the inner diameter of the male fitting 220 andmay abut the distal surface of the flange 224, thus preventing the stem210 from being inadvertently advanced within the male fitting 220. Inorder to advance the stem 210, the stem 210 may be rotated. The rotationof the stem 210 pushes the wings 461 tangentially against a structurethat can apply a tangential force to the wings 461. As a result, thewings 461 bend tangentially and fold away from the distal surface of theflange 224, thus allowing the stem 210 to advance within the malefitting 220. For example, in FIGS. 9 and 10, each of the wings 461 isdisposed within a slot 464 on the distal surface of the flange 224. Whenthe stem 210 is rotated, the rotation of the stem 210 pushes the wings461 against the sidewalls of the slots 446 and bends the wings 461tangentially, thus allowing the stem 210 to advance within the malefitting 220. Alternatively, the distal surface of the flange may includeprotrusions instead of slots, and the rotation of the stem pushes thewings against the protrusions and bends the wings tangentially, thusallowing the stem to advance within the male fitting. The locking deviceshown in FIGS. 9 and 10 is preferred because nothing needs to be brokenoff and, therefore, there are no loose pieces associated with thelocking device.

A purpose of the locking devices is to restrict the accidental orinadvertent axial advancement of the stem 210. Preferably, an operatordoes not unlock the locking device until the male connector 200 and thefemale connector 100 are joined and the stripout layers 300, 310 areremoved. If the locking device is unlocked before the connectors 100,200 are joined and the stripout layers 300, 310 are removed, the stem210 may damage the stripout layer 300 and compromise the sterility ofthe male connector 200.

In addition to the locking device, the male connector 200 may alsocomprise a ratchet structure. For example, as shown in FIGS. 2 and 3,the stem 210 may comprise first and second sets of beveled annular ribs212, 214 circumfusing the external surface of the stem 210. The ribs212, 214 may be beveled such that they project from the surface of thestem 210, extending distally toward the flange 228 of the stem 210 andforming an acute angle with the external surface of the stem 210. Thefirst set of ribs 212 is preferably spaced from the second set of ribs214 by a smooth surface 216 formed on the stem 210. A catching member280 is preferably coupled to the inner wall of the body 221 of the maleconnector 200. A distal end of the catching member 280 includes a catch282 which rests on the outer surface of the stem 210. A similar ratchetstructure is shown in FIG. 9 and disclosed in Matkovich U.S. Pat. No.5,393,101, which is incorporated by reference to support this and otherfeatures of the present invention. The ratchet structure shown in FIG. 9comprises a single set of annular ribs and preferably does not include asmooth surface section. The ratchet structure in U.S. Pat. No. 5,393,101is preferred because the stem is not retractable once the head isadvanced toward the female fitting and can only move toward the femalefitting.

The stem 210 may further include a device disposed between the malefitting 220 and the stem 210, which stabilizes the stem 210 when thestem 210 is advanced within the male fitting 220. An exemplaryembodiment of the device, as shown in FIG. 9, may include a plurality ofaxially extending ribs 480. The ribs 480 may be mounted, for example, onthe stem 210 between the O-ring 252 and the flange 228 and preferablyare equally spaced circumferentially around the stem 210. The outersurfaces 481 of the ribs 480 may define a cylinder that has a diametersimilar to the inner diameter of the male fitting 220. Thus, when thestem 210 is advanced within the male fitting 220, the outer surfaces 491of the ribs 490 contact the inner surface of the male fitting 220, whichstabilizes the stem 210 as it moves along within the male fitting 220.

In operation, to join the connectors, an operator first removes the caps183, 283 protecting the proximal ends of the connectors 100, 200 bypulling the tabs 186, 286 and tearing the strips 187, 287 along theperforations 188, 288. The operator then interlocks the connectors. Inthe illustrated embodiments, interlocking the connectors comprisessliding the forks 146 in the female connector 100 into the slots 240 inthe male connector 200 until the catches 148 abut against the distalsurface of the flange 242. As shown in FIG. 1, the forks 146 may bendslightly as the catches 148 at the ends of the forks 146 move throughthe slots 240.

The interlocking mechanism may be configured to ensure that the tabs ofthe stripout layers 300, 310 both extend in the same direction when theconnectors 100, 200 are interconnected. For example, the forks 146 andslots 240 may be arranged in sets such that the forks 146 only engagethe slots 240 when the tabs extend in the same direction. In theillustrated embodiment, one set of forks and slots are closely spacedwhile the other set of forks and slots are more distantly spaced. Thetabs, forks, and slots are all arranged such that the connectors 200will interconnect only when the closely spaced forks engage the closelyspaced slots, the distantly spaced forks engage the distantly spacedslots, and the tabs extend in the same direction from the stem.

Once the connectors 100, 200 are coupled, the stripout layers 300, 310are removed, which in the illustrated embodiment places the apertures132, 232 of the connectors 100, 200 in fluid communication with eachother. Any contaminants entrained on the external surfaces of thestripout layers 300, 310 may be removed with the stripout layers 300,310.

As each stripout layer 300, 310 is removed, one or both of the male andfemale sealing members 270, 170, which were compressed in the male andfemale sockets 245, 145, expand to contact each other and seal theconnectors 100, 200. The sealing members preferably maintain the sealthroughout the process of removing the stripout layers 300, 310. Moreparticularly, as the stripout layers are withdrawn the exposed portionsof the sealing members 170, 270 expand and contact one another, creatinga seal between the contacting exposed portions. Because contact betweenthe sealing members follows the withdrawing stripout layers, the seal isimmediately created behind the stripout layers 300, 210 as the stripoutlayers are withdrawn.

To contact the female sealing member 170, the resiliently compressiblehead portion 273 and/or neck portion 272 of the male sealing member 270axially expands from a compressed state to an expanded state where thedistance between the base 271 and head 273 portions is increased. Thehead portion 173 of the female sealing member 170 may also expand. Thehead portion 273 of the male sealing member 270 abuts against the headportion 173 of the female sealing member 170 to form the seal. Becausethe male sealing member 270 and the female sealing member 170 eachcomprise a resiliently compressible and expandable member, movement ofthe male connector 200 or the female connector 100 once they are coupleddoes not reduce the seal. The male and female sealing members 270, 170expand or compress to counteract any movement of the connectors 100, 200and tightly maintain the seal. The annular groove 163 may decrease thesurface area of the contact between the sealing members and thusincrease the axial pressure exerted on one sealing member by the other,thereby strengthening the seal. Thus, a tight, sterile connection iscreated and maintained.

Once the stripout layers 300, 310 are removed, the head 250 of the stem210 is preferably extended into the female connector 100. In order tomove the head axially, an operator unlocks the locking device, forexample, by grasping and breaking the locking tabs 260 away from theflange 228 of the stem 210 in the case of the embodiment shown in FIG.1, or by rotating the stem 210 to deform the wings 480 tangentially inthe case of the embodiment shown in FIGS. 9 and 10. The operator thenslides the flange 228 of the stem 210 axially towards the lower flange224 of the male connector 200. As the stem moves axially, the stem 210,including the head 250, moves through the male fitting 220 and thefemale connector 100 as previously described. Further, the seal 252slides along the inner wall of the male connector 200; the catchingmember 280 slides along the first ribbed surface 212 and the smoothsurface 216 and then latches along the second ribbed surface 214; andthe head 250 then lodges in the bore 134 of the female connector 100.The bore 134 is preferably tapered so the head 250 lodges in frictionalsealing engagement with the wall of the bore 134. Fluid may then flowfreely without contamination through the aperture 132 in the femaleconnector 100 and the lumen in the stem 250 via the sterile connectionof the female and male connectors 100, 200.

The connector assembly may be utilized in conjunction with various fluidsystems or devices, such as those including flexible and/or rigid fluidcontainers, a syringe, a drip chamber, a filtration device, anintravenous (IV) device, or any combination thereof. For example, theconnector assembly may be combined with intravenous (IV) devices andused to supply fluids, for example, parenteral and biological fluids. Asused herein, a parenteral fluid is a physiologically acceptable fluid,which is preferably sterile. Examples of parenteral fluids includesaline solution, i.e., isotonic (about 0.9%) sterile saline solution,and an electrolyte solution, including for example, dextrose 5% in water(D5W). Biological fluids, as used herein, are fluids originating from aliving organism, for example, blood and blood components. Examples ofbiological fluids for which the present invention may be suitableinclude whole blood, packed red cells, platelet rich plasma, plateletsand plasma.

An exemplary embodiment of a fluid system including a connector assemblyis illustrated in FIG. 11, where analogous components have the samereference numbers as the connector assembly of FIGS. 1-7. In FIG. 11,the female connector 100 of a connector assembly is connected to acontainer 600 via a conduit 10. The conduit 10, as described previously,may be connected to the female connector 100, for example, at the distalend 126, in any suitable manner, e.g., by utilizing solvents, bondingagents, hose clamps, ultrasonic welding, threaded connectors, orfriction fitting. Alternatively, the conduit 10 may be molded to thefemale connector 100 as an integral part thereof.

The conduit 10 may be connected to the container 600 through a fitment(not shown in FIG. 11) which allows fluid communication between theconduit 10 and the container 600. The fitment (not shown in FIG. 11) mayinclude a valve such as a transfer leg closure which controls fluid flowto or from the container 600. The female connector 100, the conduit 10,and the container 600 may be constructed as a single, integral unit.

The conduit 20 connected to the male connector 200 of the connectorassembly may be connected to other components comprising the fluidsystem (not illustrated). For example, the conduit 20 may be connectedto a syringe, to a drip chamber, to a patient, or to a filtrationdevice. In addition, although not illustrated, the male connector 200 ofthe connector assembly may be connected to the container 600, i.e., thepositions of the male and female connectors 200, 100 may be reversed. Insuch an embodiment, the male connector 200, the conduit 20, and thecontainer 600 may be constructed as a single, integral unit.

The container 600 as well as the conduits 10, 20, which may be utilizedin accordance with the connector assembly of the present invention, maybe constructed of any material compatible with parenteral and biologicalfluids. The composition of the container 600 and the conduits 10, 20 mayvary with the nature of the particular fluid utilized. A wide variety ofsuitable containers 600 and conduits 10, 20 are already known in theart. Exemplary containers 600 include but are not limited to syringes,flexible bags, and rigid containers. The container 600 may be formedfrom various materials such as metallic materials, glass, and plastics,including polyvinyl chloride (PVC). The container 600 preferablycomprises plasticized PVC for flexibility and strength. Typical conduits10, 20 include tubing comprising flexible plastics, such as plasticizedPVC, for ease of use. It is intended that the invention should not belimited by the type or composition of the container 600 and/or conduits10, 20 being employed.

The fluid system illustrated in FIG. 12 is similar to the fluid systemillustrated in FIG. 11 and analogous components have the same referencenumbers. In this embodiment, however, the female connector 100 may beconnected directly to the container 600. For example, the femaleconnector 100 may be fitted with a fitment such as a transfer legclosure. In contrast to the female connector 100 illustrated in FIG. 11,wherein the conduit 10 is connected to the female connector 100, theconnector 100 may be mounted directly to the fitment 602 of thecontainer 600. The female connector 100 and the container 600 may beconstructed as a single, integral unit.

As described above, the fluid conduit 20 connected to the male connector200 of the connector assembly may be connected to other components inthe fluid system. For example, the conduit 20 may be connected to asyringe, to a drip chamber, to a patient, or to a filtration device. Inaddition, although not illustrated, the male connector 200 of theconnector assembly may be connected directly to the container 600.

In operation, the male and female connectors 200,100 of the fluidsystems of FIGS. 11 and 12 may be interlocked as previously described.Once interlocked, the stripout layers 300,310 are removed, the stem 210is moved through the male fitting 200 and sealing member 270, throughthe female sealing member 170 and into the aperture 132 of the femalefitting 120, thereby forming a sterile fluid path through the fluidsystem.

FIGS. 13 and 14 illustrate an exemplary embodiment of a fluid systemwherein a modified female connector 100 of the connector assembly ismounted directly to the wall of a container 600. Once again, analogouscomponents have the same reference numerals as used in FIGS. 1-7 and11-12. In this embodiment, the female connector 100 is different fromthe previously described female connectors 100. Essentially, in thisembodiment, the female fitting 120 includes only the bracket 140. As inthe previously described embodiments, the bracket 140 may be variouslyconfigured. The bracket 140 may comprise a socket 145 or cup having anysuitable plan form, for example, the representative bracket 140 in theillustrated embodiment comprises a generally C-shaped member. A femalesealing member 170 may be disposed within the socket 145 of the bracket140 to aid the sterile connection of the connection assembly aspreviously described. In addition, the proximal end of the femaleconnector 100 may have a sealing layer, such as the previously describedfemale stripout layer 300, to further aid the sterile connection of theconnector assembly. The bracket 140 may also include a flange 142 withforks 146, as previously described, in order to aid the interlocking ofthe female connector 100 with the male connector 200. Alternativearrangements for the connection of the female and male connectors 100,200 are also possible, and may include, for example, threadedconnectors. In an alternative embodiment, the fitting 120 of the femaleconnector 100 may extend beyond the container wall into the interior ofthe container 600.

The female connector 100 may be connected to the wall of the container600 by a variety of means. In the exemplary embodiment illustrated inFIG. 13, the female connector 100 is connected to a major surface of thecontainer 600. The female connector 100 may be bonded or welded to thecontainer 600 or may be formed integrally therewith. The area of thewall where the female connector 100 is connected may be reinforced sothat the female connector 100 will not tear away a portion of the wall.The reinforcement may be in the form of a grommet or any other suitablereinforcement means.

In operation, the male and female connectors 200, 100 of the fluidsystem of FIGS. 13 and 14 may be interlocked as previously described.Once interlocked, the stripout layers 300, 310 are removed, and the stem210 is moved through the male fitting 220 and sealing member 270,through the female sealing member 170 and an aperture 132 a in thefemale fitting 120, and through the wall of the container 600, therebyforming a sterile fluid path therethrough. To facilitate piercing of thecontainer wall, the head 250 of the stem 210 may include a piercingmember. The aperture 132 a may be sized to seal against the head 250 ofthe stem 210, which is preferably tapered to provide an increasinglysnug fit and seal at the walls of the bracket 140 defining the aperture132 a. Alternatively, the female connector 100 may comprise an O-ring toprovide a fluid tight seal between the head 250 and the aperture 132 a.

The connector assembly of any of the previous embodiments can be used tomake either a wet connection or a dry connection, although preferably itis used to make a dry connection. A wet connection is one in which themale and female connectors 100, 200 are joined while there is liquid inone or both of the connectors 100, 200. A dry connection is one in whichthe connectors 100, 200 are joined without liquid in the connectors 100,200, and the fluid flow through the connectors 100, 200 is establishedafter the connectors 100, 200 are joined.

There are various ways to make a dry connection. For example, a fluidblocking mechanism may be used to block fluid flow from a fluid sourceto a connector 100, 200 before the connectors 100, 200 are joined and toopen fluid flow after the connectors 100, 200 are joined. The fluidblocking mechanism may be any device which can block and open fluid flowto a connector 100, 200. The fluid blocking mechanism may be operativelyassociated with the connector 100, 200, disposed between the connector100, 200 and the fluid source, or operatively associated with the fluidsource. If only one connector 100, 200 is connected to a fluid source,only one fluid blocking mechanism may be used. On the other hand, ifboth connectors 100, 200 are connected to a fluid source, two fluidblocking mechanisms may be used.

Shown in FIG. 15 is a preferred arrangement for a dry connection. In thearrangement, a flow blocking mechanism 710, 720 is associated with thetubing 10, 20 attached to each of the male and the female connectors100, 200. The flow blocking mechanism 710, 720 is preferably placed ashort distance from the male and the female connectors 100, 200, e.g.,within about 5 inches or more. The flow blocking mechanism 710, 720 canbe any device which can selectively open and block the fluid flow to theconnectors 100, 200, such as a valve or a clamp mounted to the exteriorof the tubing 10, 20 and pinching the tubing 10, 20 closed. Morepreferably, the flow blocking mechanism 710, 720 is a breakaway typemechanism disposed in the interior of the tubing 10, 20. The breakawaytype mechanism normally blocks fluid flow. However, when it is pinched,bent or otherwise manipulated by an operator, a portion of the mechanismmoves, e.g., breaks away, and allows fluid flow through the mechanism. Abreakaway type mechanism is disclosed in U.S. Pat. No. 4,586,928, whichis incorporated by reference to support this and other features of thepresent invention.

In a preferred method of joining the male and female connectors 100,200, the flow blocking mechanism 710, 720 is arranged such that noliquid flows past the mechanism 710, 720 to the connector 100, 200.Consequently, neither the male nor the female connector 100, 200 has anyliquid in it as they are joined. The connectors 100, 200 are joined aspreviously described such that they are locked together with the head250 of the stem 210 securely inserted within the aperture 132 of thefemale fitting 100. The flow blocking mechanism 710, 720 is then openedto allow fluid flow through the connector assembly.

Although shown and described is what are believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific methods and designs described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. One of many examples of thesealternative embodiments is a connector assembly in which anon-removable, pierceable membrane layer extends across the interior ofone or both of the sealing members. The stem may then include a piercingmember which would pierce the membrane layer(s) as the stem movesaxially into the female fitting. Consequently, the present invention isnot restricted to the particular features described and illustrated, butshould be construed to cohere with all modifications and alternativesthat may fall within the scope of the appended claims.

1. A method of making a sterile connection comprising: mating a first fitting having an aperture and a second fitting having an aperture, including positioning an end surface of a first hollow resilient sealing member opposite an end surface of a second hollow resilient sealing member and positioning first and second strip out layers between the end surfaces of the first and second resilient sealing members, wherein mating the first and second fittings includes mechanically interlocking the proximal ends of the fittings with the first strip out layer sealing the first resilient sealing member of the first fitting and the second strip out layer sealing the second resilient sealing member of the second fitting; removing the first and second strip out layers from between the end surfaces of the sealed first and second resilient sealing members; and contacting the end surface of the first resilient sealing member and the end surface of the second resilient sealing member to provide fluid communication between the aperture of the first fitting and the aperture of the second fitting.
 2. The method of claim 1 wherein mating the fittings includes abutting the first and second strip out layers.
 3. The method of claim 1 wherein mechanically interlocking the fittings includes engaging protrusions on one fitting in slots of the other fitting.
 4. The method of claim 1 wherein removing the first and second strip out layers includes moving each strip out layer from a first position in which the strip out layer is bonded beyond the periphery of the resilient sealing member to seal the resilient sealing member from the ambient environment to a second position in which the strip out layer is displaced from the end surface of the resilient sealing member.
 5. The method of claim 1 further comprising advancing a stem member through the aperture of the first fitting and into the aperture of the second fitting after removing the first and second strip out layers.
 6. The method of claim 1 wherein mating the first and second fittings includes compressing the first and second resilient sealing members.
 7. A connector assembly comprising; a first fitting having an aperture; a second fitting coupleable to the first fitting and having an aperture; a stem disposed in the aperture of the first fitting, having a head, and being axially movable through the aperture of the first fitting into the aperture of the second fitting; and a deformable locking device including an axially extending member arranged between the first fitting and the stem to selectively prevent the head from moving through the aperture in the first fitting.
 8. The connector assembly of claim 7 wherein the stem is rotatably mounted within the first fitting and the deformable locking device includes a radially extending wing mounted to the stem, wherein rotating the stem moves the wing from a first position in which the wing engages the first fitting to prevent axial movement of the stem and a second position in which the wing bends but does not break to allow axial movement of the stem within the first fitting. 